Del immune V and microbiome restructuring in colorectal cancer surgery: a randomized double blind placebo controlled trial

Introduction: The gut microbiome is increasingly recognized as a central factor in carcinogenesis. Dietary components and therapeutic interventions, including probiotics, may influence microbial composition and function, thereby modulating cancer risk. Del-Immune V, a metabiotic supplement derived from Lactobacillus rhamnosus, has demonstrated immunomodulatory properties. This study investigates its role in microbiome restructuring and patient-reported outcomes in colorectal cancer patients during the perioperative period. Materials and Methods: A randomized, controlled, double-blind Phase I trial was conducted in 39 colorectal cancer patients undergoing elective resection, assigned to Del-Immune V (n=22) or placebo (n=17). Participants received two capsules daily (100 mg each), starting 7-15 days before surgery and continuing until 15 days postoperatively. Blood and fecal samples were collected at baseline and day 60 to assess IL-6, CRP, CEA, and microbiome composition. Patient-reported outcomes were measured using the EORTC QLQ-C30 questionnaire. Microbiome profiling was performed using 16S rRNA gene sequencing with PICRUSt-based functional inference. Results: ), with a significant improvement in the dysbiosis index (p=0.024). Conclusions: Del-Immune V demonstrated immunomodulatory activity, evidenced by reductions in IL-6 and CRP, alongside improvements in patient-reported quality of life. These effects were accompanied by restructuring of the gut microbiome, characterized by enrichment of protective commensals and reduction of CRC-associated taxa. Collectively, findings support Del-Immune V as a safe adjunctive therapy in colorectal cancer surgery, with potential to enhance recovery and long-term outcomes.